U.S. patent number 4,771,775 [Application Number 06/923,209] was granted by the patent office on 1988-09-20 for anastomosis devices, kits and method.
This patent grant is currently assigned to Idea Research Investment Fund, Inc.. Invention is credited to Mahmood Fazl, Fred Gentili, William M. Lougheed, David J. Walsh.
United States Patent |
4,771,775 |
Walsh , et al. |
September 20, 1988 |
Anastomosis devices, kits and method
Abstract
Devices, kits and methods for non-suture end-to-end and
end-to-side anastomosis of tubular tissue members employ tubular
connection members having clip retaining elements comprising
annular grooves or flanges in the connection members; and spring
clips which comprise a ring-shaped body with separable opposed ends
whereby a circular opening defined by the body can be enlarged; the
opposed ends have handling elements to facilitate handling of the
clips and separation of the opposed ends; specially developed
instruments facilitate use of the devices and the anastomosis
procedure can be completed much more rapidly than with conventional
techniques and has the significant advantage of intima to intima
contact at the site of anastomosis with no foreign material exposed
to the lumen of the vessels being joined.
Inventors: |
Walsh; David J. (Mississauga,
CA), Lougheed; William M. (Toronto, CA),
Gentili; Fred (Toronto, CA), Fazl; Mahmood
(Toronto, CA) |
Assignee: |
Idea Research Investment Fund,
Inc. (Ontario, CA)
|
Family
ID: |
27083178 |
Appl.
No.: |
06/923,209 |
Filed: |
October 27, 1986 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
598900 |
Apr 10, 1984 |
4657019 |
Apr 14, 1987 |
|
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B
17/11 (20130101); A61B 17/30 (20130101); A61B
2017/1135 (20130101) |
Current International
Class: |
A61B
17/30 (20060101); A61B 17/11 (20060101); A61B
17/03 (20060101); A61B 017/11 () |
Field of
Search: |
;128/325,326,334R,334C,335,346,354 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Brickham's "Operative Surgery", 1924, p. 12 vol. 2..
|
Primary Examiner: Truluck; Dalton L.
Assistant Examiner: Wilkens; Frank
Attorney, Agent or Firm: Bachman & LaPointe
Parent Case Text
This is a division of application Ser. No. 598,900, filed Apr. 10,
1984, now U.S. Pat. No. 4,657,019, issued Apr. 14, 1987.
Claims
We claim:
1. A unitary anastomosis device for non-suture end-to-end
connection of tubular tissue members to be anastomosed
comprising:
a first substantially annular support member having a first
circular orifice therethrough,
a second substantially annular support member having a second
circular orifice therethrough,
a body member having first and second opposed ends, said first end
being integrally connected to said first support member and said
second end being integrally connected to said second support
member,
said body member being spring loaded to urge said first and second
support members into contact with said first and second circular
orifices in axial alignment,
said first and second support members being separable responsive to
pressure to said body member countering the spring loading, while
maintaining axial alignment of said first and second circular
orifices,
a first plurality of tissue retaining members on said first support
member, and
a second plurality of tissue retaining members on said second
support member,
wherein said body member has a generally U-shaped body portion
having opposed first and second leg members, said leg members
terminating at their opposed free ends in first and second arms,
said arms being in a cross-over relationship, said arms terminating
in said first and second opposed ends.
2. A device according to claim 1, wherein said U-shaped body
portion has opposed first and second sides, said first arm being
offset from said first side and adjacent said second side; and said
second arm being offset from said second side and adjacent said
first side to establish said cross-over relationship.
3. A device according to claim 2, wherein said tissue retaining
members of said first and second pluralities comprise teeth.
Description
BACKGROUND OF THE INVENTION
(i) Field of the Invention
This invention relates to the connection of tubular tissue members,
more especially blood vessels.
(ii) Description of the Prior Art
End-to-end connection of interrupted blood vessels in surgery is
generally carried out by stitching with suture material.
Stitched connections are time consuming to complete, typically
taking twenty minutes for each connection. While many surgeons have
become adept in forming stitched connections, success is very much
dependent on the skill of the individual surgeon.
The adaptation of the operating microscope to the surgery of small
vessels by Jacobson and Snarez in 1960 removed a barrier long
believed insurmountable and showed that with intricate techniques
and magnification successful suture anastomosis of vessels as small
as 1 mm in diameter was possible.
Nevertheless, in spite of continuous training and the development
of improved microscopes, instruments and sutures, many problems
remain, and it remains difficult to obtain consistently high
patency rates using suture techniques, particularly when dealing
with vessels 1 to 2 mm in diameter.
The stitching of a connection between small diameter vessels in
microsurgery presents special problems. The stitching operation is
conducted under a microscope, often in a confined area.
Stitching also has the disadvantage that a foreign material, namely
the suture is exposed at the interior blood contacting surface of
the connection, and this presents a nidus for clot formation which
in small vessel anastomosis is particularly likely to lend to
occlusion. Proposals have been made for end-to-end stitchless
connections, for example, in U.S. Pat. Nos. 3,155,095; 3,254,650;
3,254,651; 3,774,615 and 3,974,835. None of these prior proposals
has proved to be practical and the prior devices have not been used
in clinical applications.
In practice the handling and application of devices for stitchless
connections is difficult. The devices are necessarily small in size
since typically the vessels being connected have diameters in the
range of 0.75 mm to 7.5 mm, and the vessel must not be unduly
stretched.
It is extremely important that connections between blood vessels be
complete and free of leaks. Failure of the connection results in
internal bleeding which may be fatal.
There has been no previous proposal for an end-to-side non-suture
anastomosis.
Stitchless connections provide the possibility of completing
anastomosis in a much shorter time, more simply, while at the same
time avoiding the presence of foreign material at the internal
blood contacting surface of the connection.
SUMMARY OF THE INVENTION
It is an object of the invention to provide anastomosis devices for
non-suture connection of tubular, tissue members, especially blood
vessels.
It is yet another object of the invention to provide such devices
for end-to-end and end-to-side connections.
It is a further object of this invention to provide an anastomosis
kit comprising anastomosis devices for non-suture connections, and
instruments for the handling and application of the devices.
It is yet another object of the invention to provide a non-suture,
anastomosis method.
In accordance with one aspect of the invention there is provided an
anastomosis device for non-suture end-to-end connection of tubular
tissue members to be anastomosed comprising: a tubular connection
member of sterilizable, biocompatible material having an inner
cylindrical surface and an outer cylindrical surface; first and
second, spaced apart clip-retaining means on said outer surface,
first and second clip members, each clip member having a
ring-shaped body part and opposed ends separable under spring
tension, each body part defining a substantially circular opening,
the body parts of said first and second clip members being adapted
to circumferentially surround said outer cylindrical surface; said
opposed ends having opposed handling elements to facilitate
handling of said clip members and separation of said opposed ends
for application of said clip members about said tubular connection;
said clip-retaining means being effective to prevent axial
dislodgement of the clip members, mounted on said connection
member, at said first and second ends.
In accordance with another aspect of the invention there is
provided an anastomosis device for non-suture end-to-side
connection of tubular tissue members to be anastomosed comprising:
a tubular connection member of sterilizable, biocompatible material
having a smooth inner cylindrical surface, an outer cylindrical
surface, and a clip retaining means on said outer cylindrical
surface adjacent a first end of said connectoion member; clip means
of sterilizable, biocompatible spring material having a ring-shaped
body part defining a substantially circular opening, and opposed
ends separable under spring pressure to enlarge said opening, said
ring-shaped body part being adapted to circumferentially surround
said outer cylindrical surface; a plurality of spaced apart tissue
piercing and retaining members on said ring-shaped body part; said
clip-retaining means being effective to prevent axial dislodgement
of the clip member mounted on said tubular member, at said first
end.
In accordance with yet another aspect of the invention there is
provided an anastomosis kit for non-suture connection of tubular
tissue members, which comprises a plurality of anastomosis devices
of the invention of different sizes, a clip applicator comprising a
pair of opposed legs connected at one end and having support means
remote from said one end to supportingly engage the opposed
handling elements of said clip members, said legs being operable
under spring tension to separate said support means and the engaged
opposed handling elements, to enlarge said substantially circular
opening; and a holder for the connection members comprising a pair
of opposed legs connected at one end and having opposed feet remote
from from said one end, adapted to engage the inner cylindrical
surface of a connection member of said devices, said holder legs
being operable under spring tension to forcefully urge said feet in
opposite directions against opposed sides of the inner cylindrical
surface of said connection member.
In accordance with still another aspect of the invention there is
provided a method of non-suture end-to-end anastomosis of tubular
tissue members, which comprises: feeding a free end of a first
tubular tissue member through a tubular connection member from a
first end thereof, everting said free end over said connection
member, from a second end thereof; holding the everted free end on
said connection member, against anastomatic separation; applying a
second tubular tissue member over the everted free end from said
second end of said connection member; and holding said second
member on said connection member, with said everted free end
there-between, against anastomatic separation.
In accordance with a further aspect of the invention there is
provided a method of non-suture anastomosis of tubular tissue
members which comprises: feeding a free end of a first tubular
tissue member through a tubular connection member from a first end
thereof; everting said free end over said connection member from a
second end thereof, forming an expandible tissue opening in a side
of a second tubular tissue member; expanding said tissue opening to
receive said second end with the everted free end of said first
tissue member; inserting said second end in said opening; and
retracting said tissue opening into engagement with said everted
free end.
In accordance with still another aspect of the invention there is
provided an anastomosis device for non-suture end-to-end connection
of tubular tissue members to be anastomosed comprising: a first
support member having a first orifice therethrough for passage of
an end of a first tubular tissue member, a second support member
having a second orifice therethrough for passage of an end of a
second tubular tissue member, said first support member having
means to secure said end of said first tubular tissue member
thereto, said second support member having means to secure said end
of said second tubular tissue member thereto, and means adapted to
hold said first and second support members in a first position in
which the support means are in a substantially contacting
relationship with said first and second orifices in alignment, and
a second position in which said first and second support members
are in spaced apart relationship.
In yet another aspect of the invention there is provided a method
of non-suture end-to-end anastomosis of tubular tissue members,
which comprises: disposing a free end of a first tubular tissue
member through an orifice in a first support member, everting said
free end over said first support member, disposing a free end of a
second tubular tissue member through an orifice in a second support
member, everting said free end over said second support member, and
holding the everted ends of said tubular tissue members in contact
against anastomatic separation.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is illustrated in particular and preferred
embodiments by reference to the accompanying drawings in which:
FIG. 1 illustrates an anastomosis device of the invention for
end-to-end anastomosis;
FIG. 2 shows a connection cylinder, a component of the device of
FIG. 1;
FIG. 3 shows a spring clip, a component of the device of FIG.
1;
FIGS. 4A, 4B, 4C and 4D are different views of a cylinder holder
for use with the connection cylinder of FIG. 2;
FIGS. 5A, 5B, 5C and 5D are different views of a clip applicator
for use with the clip of FIG. 3;
FIGS. 6A and 6B illustrate an obturator for use in the
invention;
FIGS. 7A and 7B illustrate an anastomosis device of the invention
for end-to-end anastomosis, in a different embodiment;
FIGS. 8 to 12 show sequential steps in an anastomosis procedure of
the invention; in particular
FIG. 8 illustrates the step of measuring the internal diameter of
the separated ends of an artery which are to be connected by a
vein;
FIGS. 9A and 9B show application of parts of the device of FIG. 1
to the vein;
FIG. 10 shows the vein having connection cylinders secured at both
ends, ready to be anastomised at one end to the artery;
FIG. 11 shows the anastomization of one end of the artery to the
vein; and
FIG. 12 shows the completed anastomosis between the vein and the
separated ends of the artery;
FIG. 13 shows an anastomosis device for end-to-side
anastomosis;
FIGS. 14A, 14B and 14C show a bayonet clip holder for use in
applying a clip of the device of FIG. 13;
FIGS. 15A and 15B show a bayonet cylinder holder for use with the
cylinder of FIG. 13;
FIGS. 16A and 16B show an alternative bayonet clip holder;
FIGS. 17A and 17B show a perimeter cylinder holder for use with the
device of FIG. 13;
FIGS. 18A to 18E illustrate schematically the technique of
end-to-side anastomosis in accordance with the invention;
FIGS. 19 to 22 show sequential steps in an anastomosis procedure of
the invention, in particular:
FIG. 19 shows the formation of openings in arteries to be
connected;
FIG. 20 shows the mounting of a clip in a first artery;
FIG. 21 shows the completion of the connection between the bridging
vein and the second artery; and
FIG. 22 shows the completed connection;
FIGS. 23A and 23B show another device for end-to-end anastomosis;
and
FIG. 24 shows the final stage of an end-to-end anastomosis
employing the device of FIGS. 23A and 23B.
DESCRIPTION OF THE PREFERRED EMBODIMENTS WITH REFERENCE TO THE
DRAWINGS
With further reference to FIGS. 1, 2 and 3, a device 10 for
end-to-end anastomosis comprises a tubular connection member in the
form of a connection cylinder 12 and spring clips 14 and 16 which
suitably are coded, for example, by colour coding, to identify
either the cardiac or peripheral ends of a vein.
With further reference to FIGS. 1 and 2, the connection cylinder 12
comprises a smooth inner cylindrical surface 18 and a smooth outer
cylindrical surface 20. An annular channel 22 in outer surface 20
extends between a first annular flange 26 and a second annular
flange 28; the annular flanges 26 and 28 extend generally radially
of the outer surface 20.
With further reference to FIG. 3, spring clip 14 comprises a
ring-shaped body 30 defining a generally circular opening 31, and
opposed clip ends 32 and 34. The clip ends 32 and 34 include
eyelets 36 and 38, respectively.
Spring clip 16 is generally identical to spring clip 14 and
suitably may be slight larger.
With reference to FIG. 4, FIG. 4A shows a cylinder holder 40 having
legs 42 terminating in holder feet 44, each holder foot 44 having
an outer cylindrical surface 46. Legs 42 are joined under spring
tension at head 48.
FIGS. 4C and 4D show the cylinder holder 40 supporting the
connection cylinder 12 of FIG. 2, with the cylindrical surfaces 46
of feet 44 engaging inner surface 18 of connection cylinder 12
under spring tension.
FIGS. 5A to 5D show a clip applicator 50. With particular reference
to FIGS. 5A and 5B, applicator 50 comprises legs 52 and 54
terminating in crossed arms 56 and 58, respectively. Legs 52 and 54
are connected, under spring tension at applicator head 64, and
spikes 60 and 62 extend from arms 56 and 58, respectively.
FIGS. 5C and 5D show clip applicator 50 supporting a clip 14 of
FIG. 2, with the spikes 60 and 62 extending through eyelets 36 and
38, respectively.
With reference to FIG. 6A handle element 66 comprises an elongated
handle 72 and a tubular end 74. FIG. 6B shows an obturator 68
having a generally conical end portion 70 comprising annular
segments 76 of different defined diameters, and a truncated cone
portion 82 comprising annular segments 78 of different defined
diameters. A spigot 80 extends from obturator 68.
Suitably the annular segments 76 and 78 have diameters ranging from
0.5 to 4.5 mm, the diameters of adjacent segments 76 and 78
increasing in increments of 0.5 mm with increase in distance from
the spigot 80.
With reference to FIGS. 7A and 7B a device 200 for end-to-end
anastomosis comprises a tubular connection member in the form of a
connection cylinder 212 and spring clips 214 and 216 which are
essentially the same as clips 14 and 16 described with reference to
FIGS. 1 to 3.
The connection cylinder 212 has a smooth inner cylindrical surface
218 and a smooth outer cylindrical surface 220. Generally parallel
annular grooves 222 and 224 are formed in outer surface 220 and
define first and second ends 226 and 228 in surface 220.
The anastomosis method for end-to-end connection is further
described with reference to FIGS. 8 to 12 which illustrate a method
for forming an anastomosis between ends 84 and 86 of an artery 85;
the anastomosis being carried out with a vein 92 which is to form a
bridge between ends 84 and 86.
The anastomosis method is described by reference to the device 100
of FIGS. 1 to 3 but the device 200 of FIGS. 7A and 7B could be
employed in a similar manner.
In a first step an appropriate vein 92 for the anastomosis is
selected, is tagged to identify the cardiac end and is then removed
from the body.
The internal diameter of the vein 92 and its radial stretchability
is measured using an obturator of the type illustrated in FIGS. 6A
and 6B.
The artery 85 to be used is exposed and the free separated ends 84
and 86 are supported between clamps 88 and bridge support 90.
In order to select a connection cylinder 12 of appropriate size a
comparison is made between the stretch diameter of the vein 92 and
the internal diameter of the artery 85.
FIG. 8 particularly illustrates the use of an obturator 68 of FIG.
6B to measure the internal diameter of artery 85 at end 84.
Obturator 68 is secured to handle element 66 by inserting spigot 80
in tubular end 74. The obturator 68 is inserted into the open end
84 of artery 85. The annular segments 76 and 78 are of different
specified diameters. In this way an unstretched and stretched
diameter of the artery 85 can be determined. The unstretched and
stretched diameters of the vein 92 are determined in a similar
manner (not illustrated).
A connection cylinder 12 having an appropriate diameter is then
selected.
FIGS. 9A and 9B show schematically the application of connection
cylinder 12 to one end of vein 92. As shown in FIG. 9A vein end 94
of vein 92 is passed through a first end adjacent flange 26 and
emerges from a second end adjacent flange 28 of connection cylinder
12. Vein end 94 is then everted over connection cylinder 12 in the
manner indicated by the arrow in FIG. 9A. The everted portion 98
extends over annular channel 22 in the direction of flange 26. A
spring clip 14 is then seated in annular channel 22 adjacent flange
26 with the everted portion 98 of vein 92 thereunder.
It will be understood that the circular opening 31 of spring clip
14 has a diameter selected having regard to the size of connection
cylinder 12. The spring tension in spring clip 14 in conjunction
with the diameter of circular opening 31 and the depth of annular
groove 32 are such that ring-shaped body part 30 is firmly seated
in annular channel 22 and the everted portion 98 is securely held
on connection cylinder 12 against anastomatic separation. In other
words, the everted portion 98 is firmly held on cylinder 12 under
spring pressure, and will not become separated from the cylinder
such as to permit leakage of blood at the connection.
Vein end 96 is mounted on a second connection cylinder 12 in the
same manner, but employing a spring clip 14' over everted portion
98a (see FIG. 10). Spring clips 14 and 14' are coded differently
for use with different ends of the vein 92, so that rapid
identification of the cardiac and distal ends of the vein may be
achieved, for correct orientation of vein 92.
With further reference to FIG. 10, the vein 92 has cylinders 12
(not visible) mounted at its ends 94 and 96 (see FIGS. 9A and 9B),
and secured by coded spring clips 14 and 14', respectively. One
cylinder 12 is held by a curved cylinder holder 40 (see FIGS. 4A to
4D) which engages the interior thereof, and the end 84 of artery 85
is held open by forceps 100 having hook ends 102 which pierce the
walls of artery end 84. The cylinder 12 with everted portion 98 is
inserted into the artery 85 at end 84.
With reference to FIG. 11, insertion into end 84 is completed.
Referring particularly to FIGS. 5A, 5B, 5C and 5D, spikes 60 and 62
of applicator 50 are inserted through eyelets 36 and 38 of spring
clip 16. When legs 52 and 54 of applicator 50 are urged together
arms 56 and 58 separate thereby separating clip ends 32 and 34,
under spring tension, with enlargement of circular opening 31.
With clip ends 32 and 34 separated, and opening 31 enlarged, the
clip 16 is applied over artery end 84 and is seated over everted
portion 98 in the annular groove 22 adjacent flange 28. Release of
the inward pressure on legs 52 and 54 urges clip ends 32 and 34
towards each other under the spring tension of ring-shaped body 30.
The size of circular opening 31, the spring tension of clip 16 and
the depth of annular channel 22 in conjunction with the thickness
of everted portion 98 are selected such that spring clip 16 is
firmly seated in annular channel 22 and holds artery end 84 on
connection cylinder 12 with everted portion 98 therebetween against
anastomatic separation.
The flanges 26 and 28 prevent axial dislodgement of the clips 14
and 16 from cylinder 12, and the pressure of the clips 14 and 16 on
the underlying vein and artery walls holds the vein and artery
walls in contact on the connection cylinder 12 against anastomatic
separation.
The procedure is repeated to secure the vein 92 within artery end
86 employing spring clip 16' to complete the anastomosis as
illustrated in FIG. 12.
The curved cylinder holder 40 (FIGS. 4A to 4D) comprises legs 42
and feet 44 adapted to engage the inner surface of cylinder 12,
with vein 92 thereon. Legs 42 are connected under spring tension.
In use the feet 44 are located on opposed inner sides of cylinder
12 and are brought into contact therewith by spring tension on the
inner cylinder walls urging legs 42 away from each other.
Forceps 100 have legs 101 and crossing arms 103. Legs 101 are
connected under spring tension; finger pressure on legs 101 urging
them together produces separation of arms 103 with hook ends 102 so
that artery end 84 is opened.
In the case of the device 200 of FIGS. 7A and 7B the clips 214 and
216 are firmly seated in annular grooves 222 and 224 and hold the
tissue material of the artery and vein in connection member 212 and
in contact with each other against anastomatic separation. The
depth and width of grooves 222 and 224 may be selected such that
clips 214 and 216 may be securely seated in grooves 222 and 224
with the underlying tissue material, whereby axial dislodgement of
the clips 214 and 216, and anastomatic separation is avoided.
The device 10 of FIGS. 1 to 3 is appropriate for the anastomosis of
tubular vessels having a diameter above about 2.5 mm; the device
200 of FIGS. 7A and 7B is especially appropriate for
microanastomosis, i.e. anastomosis of vessels having a diameter of
1 to 2 mm. The thickness of the tubular vessel wall increases with
vessel diameter, and greater care is needed with vessels having
thinner walls in ensuring that the vessel wall is not damaged as a
ressult of stretching, during the eversion of the vessel end over
the connection cylinder.
In the case of device 200 the diameters of the inner and outer
cylindrical surfaces 218 and 220 are selected having regard to the
diameter of the vessel to be everted thereon, the diameter of
surface 220 being only slightly greater than that of surface 218,
and the diameter of the ends 226 and 228 is the same as that of the
outer cylindrical surface 220. Thus in microanastomosis no damage
is caused to the relatively thin vessel walls as a result of
stretching of the vessel ends over the ends 226 and 228. The
relatively shallow grooves 222 and 224 in conjunction with the
clips 214 and 216 are adequate to prevent axial or radial movement
of the anastomosed vessels.
In the case of device 100 of FIGS. 1 to 3, the thicker vessel walls
of the larger size vessels are less susceptible to damage when
being stretched over cylinder 12. The annular channel 22 is
relatively deep or otherwise stated the diameter of flanges 26 and
28 is significantly larger than the diameter of outer surface 20;
the diameter of outer surface 20 being only slightly larger than
the diameter of inner surface 18.
Thus the depth of channel 22 forming relatively large diameter
flanges 26 and 28 compensates for the absence of discrete annular
grooves similar to grooves 222 and 224 in the device 200, to
accommodate clips 14 and 16. The flanges 26 and 28 defined by the
deep channel 22 serve to prevent axial dislodgement of clips 14 and
16 from cylinder 12; and in addition their relative diameter is
such that even if some radial opening or displacement of the clips
14 and 16 occurs, the partially opened clips 14 and 16 will not
pass over flanges 26 and 28.
The relatively deep channel 22 also serves to accommodate any
bunching or folds of thicker walled vessels, and ensures that such
folds are held on the cylinder 12 between flanges 26 and 28.
The device 200 can also be employed for anastomosis of larger
vessels, however, the device 10 is found to be less suitable for
microanastomosis.
With further reference to FIG. 13, a device 110 for end-to-side
anastomosis comprises a tubular connection member in the form of a
connection cylinder 112 and spring clip 114.
Connection cylinder 112 has a smooth inner cylindrical surface 116,
a smooth outer cylindrical surface 118 and annular flanges 120 and
122 at opposed ends. Annular flange 120 has opposed flat walls 124
and a spike 125 extending from each wall 124.
Spring clip 114 includes a ring-shaped body 126 defining a
substantially circular opening 127, and clip ends 128 and 130
having eyelets 132 and 134, respectively.
Tines 136 extend substantially radially outwardly from ring-shaped
body 126.
The cylinder 112 is suitably made of stainless steel. The flange
120 prevents the donor vessel and cylinder 112 from slipping into
the lumen of the recipient vessel. Outer cylindrical surface 118 is
suitably of relatively short length so that clip 114 may fit snugly
between flanges 120 and 122 and prevent protrusion of the graft
donor vessel into the lumen of the recipient vessel.
With further reference to FIGS. 14A to 14C a bayonet clip
applicator 146 comprises legs 154 and 156 joined under spring
tension at head 152. Crossing arms 158 and 160 extend from legs 154
and 156, respectively and terminate in spikes 162.
A spring loaded stabilizer arm 163 having a spring 167 extends
between legs 154 and 156, and arms 158 and 160, in a casing 166,
and terminates in a stabilizer foot 164.
Stabilizer arm 163 includes a locking arm 165 which engages a
recess 169 in leg 156 to firmly locate arm 166.
Stabilizer arm 163 is urged downwardly by spring 167 but is
restrained against downward movement, as shown in FIG. 14A, by
locking arm 165 which engages recess 169. When locking arm 165 is
released from recess 169 the stabilizer arm 166 moves downwardly
under the action of spring 167 and stabilizer foot 164 lightly
engages clip ends 128 and 130 of clip 114 and stabilizes the
location of clip 114 during the enlargement of opening 127 and
insertion of the cylinder 112. The opening 127 is enlarged for the
insertion of cylinder 112 by pressing legs 154 and 156 towards each
other.
With further reference to FIGS. 15A and 15B, a bayonet cylinder
holder 148 comprises upper legs 170 and 172 and lower legs 174 and
176 terminating in holder feet 175. Legs 174 and 176 are off-set
relative to legs 170 and 172.
The holder feet 175 have toes 179 with outer cylindrical surfaces
for engaging the inner surface 116 of cylinder 112.
Upper legs 170 and 172 are connected at head 177 under spring
pressure.
The off-setting of legs 174 and 176 relative to head 177 and legs
170 and 172 avoids obstruction in the line of vision of the
surgeon.
With further reference to FIGS. 16A and 16B there is shown an
alternative bayonet clip applicator 178. Applicator 178 has legs
180 and 182 and crossing arms 184 and 186 terminating in feet 185
having spikes 187. Legs 180 and 182 are connected under spring
tension at head 189.
Applicator 178 functions in the same manner as applicator 50 in
FIGS. 5A, 5B, 5C and 5D, however, the off-setting of arms 184 and
186 relative to legs 180 and 182 avoids obstruction in the line of
vision of the surgeon.
With further reference to FIGS. 17A and 17B a perimeter cylinder
holder 190 comprises upper legs 191 and 192 and lower legs 193 and
194 terminating in feet 195. Legs 193 and 194 are off-set relative
to legs 191 and 192.
Legs 191 and 192 are connected at head 196 under spring
pressure.
A spring leaf locking arm 197 includes an upper arm 198 mounted on
leg 191 and a lower arm 199 having a projecting stop 201. A recess
203 having a stop 204 is defined in leg 192.
Feet 195 are urged apart by the spring pressure as shown in FIG.
17A. Legs 191 and 192 are urged towards each other by finger
pressure until feet 195 engage opposed outer sides of cylinder 112,
and are locked in position under the spring action of arm 197
urging lower arm 199 into recess 203, where it is held by
engagement of stops 201 and 204.
With reference to FIGS. 18A, 18B, 18C, 18D and 18E, the end-to-side
anastomosis technique is illustrated schematically.
FIGS. 18A and 18B show the mounting of a vein 500 on connection
cylinder 112 of FIG. 13, the everted portion 502 being held by the
spikes 125.
FIGS. 18C and 18D show the mounting of a clip 114 around an opening
in an artery 510 to form a circular opening corresponding to
opening 127 of clip 114, and bounded by tissue annulus 550.
FIG. 18E shows the completed anastomosis in which flange 122 of
cylinder 112 is disposed below clip 114 and prevents axial
dislodgement of clip 114.
The end-to-side anastomosis technique is illustrated in a stepwise
fashion in FIGS. 19 to 22.
Flow of blood is interrupted in arteries 510 to 512 to be
connected, by means of clamps 544; a vein 500 is to be anastomosed
between the arteries 510 and 512.
As shown in FIG. 19 an opening is formed in each of arteries 510
and 512 suitably by applying two incisions at right angles forming
a cross in the tissue material (see artery 510 in FIG. 19). The
artery tissue adjacent the incisions is folded back (see artery 512
in FIG. 19).
With reference to FIG. 20, the folded back tissue of artery 512 is
inserted upwardly through opening 127 in clip 114 and is secured
over ring shaped body 126 by the tines 136 as illustrated
schematically in FIGS. 18C and 18D. Forceps 515 are employed to
draw the folded back tissue over the tines 136. During this
operation the clip 114 is supported by the clip applicator 146 of
FIGS. 14A to 14C.
There is thus formed a generally, circular expandible tissue
opening into artery 512 corresponding to circular opening 127 of
clip 114, and bounded by tissue annulus 550.
An end of vein 500 is passed through connection cylinder 112 and
everted thereover in the general manner illustrated in FIGS. 18A
and 18B, the vein 500 being everted over the flanges 120 and 122
being pierced by spikes 125 to form the everted portion 502.
A final stage of the anastomosis is illustrated in FIG. 21, wherein
the connection of vein 500 to artery 512 is already completed and a
similar connection between vein 500 and artery 510 is about to be
completed.
As shown in FIG. 21 eyelets 132 and 134 of clip 114 mounted in
artery 510 are engaged by the spikes 162 of bayonet clip applicator
146.
Inward pressure on legs 154 and 156 of applicator 146 causes spikes
162 to separate, thereby separating clip ends 128 and 130 and
enlarging circular opening 127 which in turn enlarges the diameter
of tissue annulus 550.
Cylinder 112 with vein 500 mounted thereon is held by bayonet
perimeter cylinder holder 190 (see FIGS. 17A and 17B) and is then
inserted into the enlarged opening 127 so that flange 122 of
cylinder 112 is disposed on the interior side of ring-shaped body
126 (see FIG. 18E), within artery 510 and ring-shaped body 126 is
disposed about outer surface 118. During this insertion stabilizer
arm 166 applies pressure on clip ends 128 and 130 to firmly
position spring clip 114 for insertion of cylinder 112 and its
mounted vein 500.
Thereafter pressure on legs 154 and 156 is released so that they
move apart under spring pressure and arms 158 and 160 move towards
each other to their normal position and clip ends 128 and 130
likewise are urged towards each other. In this way clip 114 is
firmly located under spring tension over outer surface 118 with the
everted portion 502 of vein 500 therebetween.
The flanges 122 and 120 and spikes 125 prevent axial separation of
clip 114 from cylinder 112 and the pressure of clip 114 holds
tissue annulus 550 in contact with the everted portion 502 of vein
500 whereby anastomatic separation is avoided.
The spring tension in body 126 and the dimensions of flange 122 are
such that opening 127 can be enlarged to a diameter greater than
that of flange 122 for insertion of cylinder 112 with vein 500
mounted thereon into tissue annulus 550.
With further reference to FIG. 22, there is illustrated the
completed end-to-side anastomosis.
With further reference to FIGS. 23A and 23B there is shown an
anastomosis clip 600 having a pair of legs 602 and 604 and
cross-over arms 606 and 608. Arms 606 and 608 terminate in aligned
rings 610 and 612. Rings 610 and 612 have circular orifices or
openings 614 and 616 which form a continuous orifice 615.
Ring 610 has a plurality of spaced apart, outwardly extending teeth
618 and ring 612 has a similar plurality of teeth 620.
Legs 602 and 604 are connected at head 622 under spring pressure
which tends to urge legs 602 and 604 away from each other, thereby
urging rings 610 and 612 into contact with each other as shown in
FIG. 23A. Pressure on legs 602 and 604 forces them together thereby
forcing rings 610 and 612 apart, as shown in FIG. 23B.
A small gap 624 is defined in ring 612.
The anastomosis clip 600 is particularly suitable for anastomosis
of vessels having a diameter greater than 2 mm.
The anastomosis technique employing clips 600 is illustrated in
FIG. 24 in which the separated ends 684 and 686 of an artery 685
are connected with a vein 692. In FIG. 24 the two clips are
identical but for convenience the parts of one clip are
additionally designated by the letter `a`.
Clips 600 and 600a having orifices 615 and 615a are selected
according to the dimensions of artery 685 and a vein 692 of
appropriate dimensions is selected.
As shown in FIG. 24 the anastomosis of end 684 and vein 692 with
clip 600 is complete; the technique is described by reference to
the anatomosis of end 686 and vein 692 with clip 600a.
In the first stage of the anastomosis (not illustrated) the clips
600 and 600a are connected to the ends of vein 692, the artery end
684 is connected to clip 600 and finally the artery end 686 is
connected to clip 600a.
In order to connect a free end of vein 692 to clip 600a, the
surgeon squeezes legs 602a and 604a together to separate rings 610a
and 612a.
The free end of vein 692 is fed through orifice 614a of ring 610a
and is everted over teeth 618a thereby forming an annulus of vein
tissue 650a.
In the final stages (illustrated in FIG. 24) the end 686 of artery
685 is feed into orifice 616a, and is everted over teeth 620a
thereby forming an annulus of artery tissue 652a.
The pressure urging legs 602a and 604a together is released so that
rings 610a and 612a are urged towards each other whereby annulus
650a firmly contacts annulus 652a, annuli 650a and 652a being held
against anastomatic separation by the spring pressure.
Similar annuli 650 and 652 are held together by clip 600, and in
this way a continuous wall of tissue material is formed between
artery ends 684 and 686 and normal flow of blood can resume.
It will be recognized that in both the end-to-end anastomosis
illustrated in FIGS. 8 to 12; and the end-to-side anastomosis
illustrated in FIGS. 19 to 22, there is no exposure of devices 10
and 110 at the lumen, or interior wall of the arteries and veins.
This represents a significant advantage over conventional suture
techniques.
The anastomosis technique has been particularly described, with
reference to the drawings, for the joining of completely separated
vessel ends. It is, however, possible to employ the same devices
and techniques to complete a connection between a partly separated
wall of a tubular vessel. For example, when an aneurysm occurs, the
artery wall bulges and creates a weak spot in the wall which may
burst under the pressure of the blood. In accordance with the
invention the artery may be partially severed around the aneurysm
and the separated edges of the artery wall may be joined using the
devices of the invention to by-pass the aneurysm.
In this case the gap 624 in ring 612 of clip 600 may serve for
introduction of the unsevered portion of the artery into clip
600.
Employing the anastomosis devices and instruments of the invention
the surgeon can readily hold and support the devices during the
anastomosis. It will be understood that the surgeon is working in a
very small area under a microscope, and so in developing a
satisfactory and practical technique it is important that one
person, namely the surgeon, be able to hold and apply the principal
components of the anastomosis devices during the anastomosis.
For example, in end-to-end anastomosis, it is necessary that the
connection cylinder be held still during application of the spring
clip. By means of the instruments of the invention the surgeon is
able to hold the connection cylinder with the everted vein with one
hand for insertion of the cylinder into the artery held open with
the other hand. Still holding the cylinder inserted in the artery
with one hand, the surgeon can hold the spring clip and open and
apply it with the other hand. In this regard it has been found to
be particularly important that the person holding the cylinder also
applies the spring clip so that his hands remain axial and the
cylinder is mounted on the true axis of the artery to be
anastomosed.
One of the shortcomings of prior proposals for non-suture
anastomosis has been the absence of instruments to hold, support
and apply the devices. This is especially important since the
anastomosis devices are of very small size being intended for
connecting vessels having diameters of 0.75 to 7.5 mm. The kit of
the invention thus represents an especially important embodiment of
the invention.
The anastomosis procedure of the invention has also been made
applicable to microanastomosis and to long vein intercranial bypass
procedures. For this purpose cylinder holders and clip applicators
have been developed suitable for use in fine deeply situated
regions at the base of the brain. To meet these purposes
instruments have been developed of increased length and
incorporating a bayonet design to allow a more direct,
unobstructed, view and facilitate anastomosis.
The bayonet cylinder holder described above has its cylinder
engaging end offset relative to the handle, thus the handle does
not obstruct the surgeon's view of the anastomosis site. The
bayonet cylinder holder is thus especially suitable in
microanastomosis of 1 mm vessels in a confined space.
By way of example, connection cylinders 12 and 112 typically have
diameters of 3.5 mm, 3 mm, 2.5 mm, 2 mm, 1.5 mm, 1.0 mm and 0.75
mm, with a wall thickness of 5 thousandths of an inch. The length
of the connection cylinder is suitably of the same order as the
diameter. Suitably the cylinders are made of stainless steel.
Spring clips 14 and 16 are suitably of metal or metal alloy wire,
for example, Elgiloy wire, typically having a wire diameter of 7 to
18 thousandths of an inch. Typically these clips may have diameters
of 3.5 mm, 3 mm, 2.5 mm, 2 mm, 1.5 mm, 1.0 mm and 0.75 mm.
Elgiloy is a cobalt base alloy of the following composition in
weight %:
Co: 40%
Cr: 20%
Ni: 15%
Mo: 7%
Mn: 2%
Be: 0.4%
C: 0.15%
Fe: 15.81%
The clips fabricated from the wire are suitably heat-treated to
provide spring tension characteristics. By way of example the clips
are heated with a propane torch to a light straw colour at an
elevated temperature.
Employing the non-suture technique of the invention the surgeon can
complete a connection much more rapidly than with conventional
techniques and has the significant advantage of intima to intima
contact at the site of anastomosis with no foreign material exposed
to the lumen of the vessels being joined. In particular employing
the non-suture technique of the invention the surgeon can complete
a connection regardless of vessel size, including a microvascular
anastomosis of 1 mm diameter vessels typically in a time of less
than three minutes. Such microvascular anastomosis employing
conventional suture techniques, even with use of a microscope,
requires a significantly longer time, typically 20 to 40
minutes.
RESULTS
End-to-End:
Table I shows the results of in vivo end-to-end anastomosis in dogs
employing the procedure and devices of the invention. Seventeen
vascular anastomoses are carried out in five dogs. Carotid, femoral
and axillary vessels were used with diameters ranging from 2 to 3.5
millimeters. Control angiograms were taken, following anastomosis,
for selected animals. The patency rate in the anastomoses that have
had post-operative angiography has been 91%. There has been only
one anastomosis that has not been visualized on post-operative
angiography and it is uncertain whether this is related to
occlusion of the anastomosis or to technical factors in performing
the angiogram.
TABLE 1 ______________________________________ DIAMETER PATENCY DOG
NO. VESSEL (mm) (angio) ______________________________________ 666
Right Carotid 3.0 P Left Carotid 2.5 P Left Carotid 2.5 -- Right
Femoral 3.2 P 668 Right Carotid 2.5 P Left Carotid 2.5 P Right
Femoral 2.5 P Left Femoral 2.0 -- Left Axillary 2.0 -- 669 Right
Carotid 3.5 P Left Carotid 3.0 P Right Femoral 3.5 -- 702 Right
Carotid 4.0 O Left Carotid 3.0 P Right Femoral 3.0 P 716 Right
Carotid 3.5 -- Left Carotid 3.5 -- No angio
______________________________________ -- Angiogram not carried
out. O Anastomosis not visualized on angiography.
Table 2 shows the results of in vivo end-to-end anastomosis in
other dogs. Thirty three vascular anastomoses have been carried out
in 11 dogs. Carotid, femoral and axillary vessels were used with
diameters ranging from 1 to 3.5 mm. These animals have been
followed for up to eight months following anastomosis (Table 2).
The patency rates in the anastomoses that have had post-operative
angiography have been 88%. Indeed, three of the four occlusions
have been in brachial vessels which have been found unsuitable for
anastomosis because of the excessive twisting of the graft in the
axilla on movement of the limb of the dog when ambulating. If the
brachial vessels are eliminated the patency rate is over 95%.
TABLE 2 ______________________________________ DIA- DOG VESSEL
METER FOLLOW UP PATENCY NO. (artery) (mm) (months) (angio)
______________________________________ 741 Right carotid 3.0 3.0 P
Left carotid 3.5 1.5 P Right femoral 3.0 2.0 P 740 Right carotid
3.5 3.0 P Left carotid 3.0 2.5 P Right femoral 1.0 3.0 O 739 Right
carotid 3.0 1.5 P Left carotid 3.0 2.0 P Right femoral 2.5 2.0 P
726 Right carotid 3.5 6.0 P Left carotid 3.5 4.0 P Right brachial
2.5 6.0 O Left brachial 2.5 6.0 P Right femoral 3.5 6.0 P Renal 3.0
4.0 P 718 Right carotid 3.5 1 week P Left carotid 3.5 1 week P 717
Right carotid 3.0 3.0 P Left carotid 3.0 3.0 P Right Brachial 2.5
2.0 P Left Brachial 2.5 2.5 P Right femoral 3.0 3.0 P 716 Left
Brachial 1.0 2.0 P Left femoral 2.5 2.5 P 702 Left brachial 1.0 1.0
P Right brachial 1.0 1.0 P 669 Right brachial 2.0 2.0 P 668 Right
brachial 2.0 1.0 P Left brachial 2.0 8.0 P Left femoral 2.0 7.5 P
666 Right brachial 2.0 1.0 P Left brachial 2.5 1.0 O Left carotid
2.5 7.0 P ______________________________________ P: Patent O:
Occluded
End-to-Side:
Assessment of graft patency, end-to-side.
In vitro experiments, using cadaver vessels, showed that the
end-to-side device of the invention produced a functioning
watertight anastomosis. Results with in vivo animal experiments
have also been encouraging. Fourteen anastomoses were performed. In
twelve procedures vein grafts were used between two arteries and
end-to-side anastomosis performed at both ends. In two procedures
single end-to-side anastomosis was done between two vessels. Thus a
total of twenty six end to side prostheses were used in the
preliminary assessment of the new method.
Further studies are continuing in the rabbit.
The rabbit's carotid artery has a diameter that ranges between 1.5
mm to 2 mm. Appropriate size clips were developed. To assess for
graft patency both angiography and direct gross inspection of the
anastomotic site has been carried out. A 100% patency rate has been
achieved with the end-to-side anastomotic devices of the invention
in those animals having had postop assessment. This includes
anastomoses in vessels ranging in size from 2 mm to 3.5 mm.
Although these animals have to date been followed over only a few
months, longer follow up studies will be carried out.
TABLE 3 ______________________________________ VESSEL DIAMETER
PATENCY (artery) (mm) (angio)
______________________________________ A. End-to-side anastomosis
DOG No. 723 Right brachial 1.5 P 738 Right brachial 2.0 NA Left to
right carotid 3.0, 2.5 NA 739 Right to left carotid 3.0, 3.0 P Left
brachial 2.0 P 741 Right to left carotid 2.5, 3.0 P Right brachial
2.0 P 740 Right brachial 1.5 P Left to right carotid 3.5, 3.5 P 760
Right to left carotid 3.0, 3.0 P Left to right carotid 3.0, 3.0 P
Right brachial 2.5 P Left brachial 2.5 P RABBIT No. 339 Right to
left carotid 2.0 P B. End-to-end anastomosis RAT No. 295 Carotid
1.0 P 278 Carotid 1.0 P 247 Carotid 1.0 P 248 Carotid 1.0 P
______________________________________ P: Patent O: Occluded NA:
Angio not done to date.
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